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2006-01
2021-10
2024-06
80
NCT02845258
Sahlgrenska University Hospital
Sahlgrenska University Hospital
OBSERVATIONAL
Treatment of Pancreatic Pseudocysts by Endoscopic Ultrasound-guided Drainage
Patients may evolve pseudocysts of the pancreas secondary to a severe pancreatitis. In case of a symptomatic or infected pseudocyst, a therapeutic drainage of the cyst is indicated. In modern medicine the preferred way to perform such a drainage is by the means of endoscopic ultrasound (EUS). It is not precisely elucidated how this EUS-procedure should be performed in different scenarios. The cyst appearance and the drainage stents and/or technique may impact the clinical outcome. This study is a prospective, single-center observational study on the outcome after EUS-guided drainage of pancreatic pseudocysts.
Patintes referred to Sahlgrenska University hospital for an EUS-guided drainage of a pseudocyst are eligible for inclusion. The drainage is performed at the discretion of an experienced endosonographer. Thus, the equipment and the technique used may vary among patients but no randomization is done before the procedure. Intraprocedural variables are registered as well as data and outcome parameters from the clinical follow up according to below.
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2016-07-20 | N/A | 2023-06-27 |
2016-07-22 | N/A | 2023-06-28 |
2016-07-27 | N/A | 2023-06 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
N/A
Allocation:
N/A
Interventional Model:
N/A
Masking:
N/A
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Short time complication rate | The number of EUS-procedure-related complications such as bleeding, infection and death. | Uo to 48 hours |
| Repeated drainage frequency | A successful drainage means no need for additional drainage procedures. The need for a repeated drainage is to be regarded as a therapeutic failure. The number of repeated procedures due to the need for additional drainage is recorded. | Up to 3 months |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Hospital stay | The number of days spent in hospital post-EUS-drainage | Up to 30 days |
| Long time complication rate | Infections and other complications related to the non-complete drainage of the pseudocyst after discharge from the hospital | Up to 6 months |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
|
Study Contact Name: Per Hedenström, MD Phone Number: +46 703 288291 Email: per.hedenstrom@vgregion.se |
Study Contact Backup Name: Riadh Sadik, Ass prof Phone Number: +46 733 641355 Email: riadh.sadik@vgregion.se |
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
NPCF was founded on May 29, 2009 and is a 501(c)(3) organization. All donations are tax deductible.
The information and services provided by the National Pancreatic Cancer Foundation are for informational purposes only. The information and services are not intended to be substitutes for professional medical advice, diagnosis or treatment. The National Pancreatic Cancer Foundation does not recommend nor endorse any specific physicians, products or treatments even though they may be mentioned on this site.
